FLOT before Surgery versus Perioperatively for the Treatment of Gastric and Gastroesophageal Junction Cancers, TOGAR Trial

Inclusion Criteria

• Must provide written informed consent
• Must be ≥ 18 years of age
• Must have life expectancy of greater than 3 months
• Must have pathologically proven Siewert type II or III GEJ or gastric adenocarcinoma from the main tumor or local lymph nodes (pre-neoadjuvant chemo)
• Stage cT2 or higher, any N and M0, are eligible for the study
• M0 disease must be established by both negative distant metastatic disease on imaging AND negative diagnostic laparoscopic assisted cytology of peritoneal fluid cytology not more than 28 days before registration
• Must be a candidate for neoadjuvant chemotherapy
• Must be a candidate for curative surgical approach
• Must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Male or female subjects of childbearing potential must be willing to use contraceptive precautions throughout the trial and for 3 months after discontinuation of study treatment. Female subjects of childbearing potential must have a negative pregnancy test within 28 days of registration. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential
• Hemoglobin ≥ 8.0 gm/dL (packed red blood cells [PRBC] transfusion is allowed to meet this criteria) (within 28 days prior to registration)
• Absolute neutrophil count (ANC) ≥ 1000 cells/mm^3 (within 28 days prior to registration)
• Platelet count ≥ 100,000 /mm^3 (within 28 days prior to registration)
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (within 28 days prior to registration)
• Aspartate transaminase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) ≤ 3.0 times the ULN (within 28 days prior to registration)
• Serum creatinine ≤ institutional upper limit of normal (IULN) OR calculated creatinine clearance ≥ 60 mL/min. This serum creatinine result must be obtained within 28 days prior to registration
• Subjects who have required a short course urgent single modality non curative radiation treatment or gastric artery embolization for the purpose of tumor bleeding control are eligible
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, current non-advanced prostate cancer per the discretion of the investigator, and any other cancers from which the patient has been disease free for two years

Exclusion Criteria

• Positive cytology or histology for metastatic disease on diagnostic laparoscopy peritoneal fluid. Reports such as: “cannot rule out malignancy” or “suspicious for malignancy, but not definitive” will exclude the subject from enrolling
• Seiwert type I GEJ cancer
• Subjects with clinical evidence of metastatic disease
• Biopsy proven metastatic disease (excluding regional lymph nodes)
• Prior chemotherapy for gastric cancer or GEJ cancer
• Female subjects who are pregnant, breast feeding, or of childbearing potential with a positive pregnancy test prior to baseline. Women of childbearing potential must have a negative serum pregnancy test as a part of eligibility within 28 days of registration. A persistent positive or elevated urine or blood beta human chorionic gonadotropin (HCG) test may be contributed to the primary diagnosis of gastric carcinoma (GC) or GEJ cancer after ruling out ectopic and intrauterine pregnancy and germ cell tumors
• Subjects unwilling or unable to comply with the protocol or provide written informed consent
• Any medical condition that, in the opinion of the investigator, would exclude the subject from participating in this study and treatment plan
• ECOG > 2